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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
EC Number:
410-800-5
EC Name:
A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
Cas Number:
143239-08-1
Molecular formula:
There is no molecular formula available, as the reference substance is a multi- constituent reaction mass. The molecular formulae of the constituents are documented in section 1.2.
IUPAC Name:
Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
Details on test material:
- Physical state: white powder
- Storage condition of test material: room temperature under silica gel

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 10-14 weeks old
- Weight at study initiation: 234-243 g (males) 207-229 g (females)
- Fasting period before study:
- Housing: individually
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 60-75
- Air changes (per hr): 15
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 23 September 1992 To: 7 October 1992

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no data
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage (Hypertie). The bandage was further secured with a piece of BLENDERM wrapped around each end.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin and surrounding hair were wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24 hr


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes


Duration of exposure:
24 hr
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
No statistics were performed.

Results and discussion

Preliminary study:
No preliminary study was performed.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
No data

Any other information on results incl. tables

Table 7.2.3/2: Number of animals dead

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity(#/total)

Male

Female

Combined

Male

Female

Combined

2000

 0

 0

 0

 -

 0

 0

 0

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, the acute dermal median lethal dose of ITC 288 in the rat was found to be greater than 2000 mg/kg bodyweight. The test substance is not classified according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).
Executive summary:

In an acute dermal toxicity study (Tuffnell, 1992), male and female Sprague-Dawley rats were dermally treated for 24 hours with ITC 288, up to at least 10 % of the body surface was in contact with the test material, at a dose level of 2000 mg/kg bw. Animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination. There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. Moreover, body weight gains were acceptable during the study period. Under the conditions of this test, the LD50 of ITC 288 in rats is greater than 2000 mg/kg bw. Based on these results, no classification is required according to the EU legislation ( CLP regulation (1272/2008) and Directive 67/548/EEC).

This acute dermal study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study.